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NCT ID: NCT06046131 Recruiting - Neoplasm Metastasis Clinical Trials

Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.

KP-CARAIBES
Start date: February 28, 2023
Phase: N/A
Study type: Interventional

The course and progression of prostate cancer is highly variable, depending on the individual characteristics, the aggressiveness of the disease at the time of diagnosis as well as the ethno-geographic origins of the individuals. The general objective of the project is to identify the clinical, genetic and environmental determinants (risk factors) of the evolution, progression and complications of the disease according to the treatment options. Identifying modifiable and non-modifiable prognostic determinants of disease progression is a major challenge. This knowledge will help guide treatment choices but also, especially in high-risk populations (high incidence of disease) to better tailor prevention policies and possibly screening .

NCT ID: NCT06046118 Recruiting - Clinical trials for Age-Related Macular Degeneration

Photobiomodulation in Dry Age Related Macular Degeneration

DRUSEN
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are: - Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD? - Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group. Treatment consists in two cycles with two phases each: - 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened; - 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened. Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks). Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.

NCT ID: NCT06045975 Recruiting - Clinical trials for BCLC A Hepatocellular Carcinoma Non-resectable and Not Amenable for RFA

Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by Electroporation Ablation

DUMELEP
Start date: March 28, 2024
Phase: Phase 2
Study type: Interventional

This project is a Phase 2 trial testing the safety and efficacy of treatment with Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting in patients with BCLC A HCC treated by percutaneous irreversible electroporation (IRE) in a curative intent. DUMELEP is a Multicentre, Phase 2 trial Eligible patients will receive consecutively: 1. 1 Durvalumab 1500 mg/Tremelimumab 300 mg infusion in a neoadjuvant setting 2. IRE procedure in a curative attempt at Day 30 3. 11 monthly Durvalumab 1500 mg infusions. 4. Classical follow-up during an additional year (every 3 months)

NCT ID: NCT06045897 Recruiting - Schizophrenia Clinical Trials

EEG Microstates Across At-Risk Mental States

DEMETER
Start date: May 30, 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to compare subjects with at-risk-mental-state, early psychosis, schizophrenia, depression, and autism spectrum disorders, with healthy controls (N = 21 x 6). The main questions it aims to answer are: - are EEG microstate anomalies associated with diagnosis, clinical and functional prognosis, both in resting conditions and during sleep ? - are EEG microstates anomalies associated with differences in sensorimotor integration, prosodic and conversational, interoceptive, and narrative self ? - an ancillary study will be to see whether in healthy controls EEG microstate properties vary under light hypnosis conditions. Participants will: - undergo deep phenotyping based on psychopathology and neuropsychological assessments - undergo a high-resolution EEG (64 electrodes) with a resting period and a sensorimotor task; and healthy controls will have a light hypnosis period. - undergo a recording of the characteristics of their voice (tone, prosody) - undergo a one-night polysomnography - undergo MRI and biological sampling for multi-omic analyses - undergo a virtual reality experience

NCT ID: NCT06045819 Recruiting - Clinical trials for Adult Acute Myeloid Leukemia

Relation Between Venetoclax Plasma Concentration and Remission in Adults With Acute Myeloid Leukemia (PREDICLAX)

Start date: April 8, 2024
Phase:
Study type: Observational

Background: In combination with hypomethylating drugs, venetoclax has recently changed the therapeutic management of patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induction chemotherapy was not an option. Over and above the clinical benefits of this combination, the data show that more than half the patients did not show remission criteria, even after the first month's exposure to venetoclax. Hypothesis: To compare the mean residual venetoclax plasma concentrations obtained in patients who went into complete composite remission versus those who did not go into remission at the end of the first cycle of venetoclax + azacitidine treatment. Method: According to the French law, this is a multicenter, non-comparative, open-label, single-arm, interventional study with minimal risks and constraints. Selection, information and inclusion will concern adult patients (≥60 years) with a confirmed diagnosis of AML according to ELN 2022 guidelines. Included patients will be treated as standard care with a combination of venetoclax+azacitidine. This research protocol will not modify their usual care.

NCT ID: NCT06045806 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06045702 Not yet recruiting - Cystic Fibrosis Clinical Trials

Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation

CFTR-EP
Start date: September 2023
Phase:
Study type: Observational

The aim of this observational study is to better understand the role and involvement of the regulatory elements of the CFTR gene, with the aim of better describing the 3D organisation of chromatin at the CFTR locus in epididymal cells in patients with male infertility of any kind, or with cystic fibrosis or bilateral agenesis of the vas deferens, requiring scheduled surgery. The main questions it aims to answer are: - to better characterise this 3D organisation of the CFTR locus, the study of regulatory elements in primary epididymal cells is the most relevant and realistic model. - to gain a better understanding of the regulation of the CFTR gene in epididymal cells in order to gain a better understanding of the pathology of male infertility caused by bilateral agenesis of the vas deferens, a symptom and also a borderline form of cystic fibrosis. Participants will Epididymal samples will be taken by a urologist for the AMP department during the planned surgery. The rest of the samples taken will be recovered for research purposes, with the aim of recovering the epididymal cells contained in the sample. This is in no way an additional procedure and will have no impact on the patient's health..

NCT ID: NCT06045689 Recruiting - Clinical trials for Myelodysplastic Syndromes

A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants

MAXILUS
Start date: October 5, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Luspatercept when administered at the maximum approved dose in low-risk Myelodysplastic Syndrome participants who require red blood cell transfusions.

NCT ID: NCT06045234 Recruiting - Toxicology Clinical Trials

Temporal Variation of the Exposure to Pesticides in the Employees of the Limoges University Hospital

VESTAL
Start date: October 17, 2023
Phase: N/A
Study type: Interventional

In a sample of 300 employees of the Limoges University Hospital, it is proposed to explore the intraindividual and interindividual variability of urinary concentrations of glyphosate and 320 other pesticides. The employees will fill a questionary in which will allow to explore the relationships between the concentrations, lifestyle and dietary habits.

NCT ID: NCT06045065 Recruiting - Brain Metastases Clinical Trials

Preclinical Brain Tumor Models

HITCH
Start date: January 2, 2022
Phase:
Study type: Observational

Background: Primary or secondary brain tumors (metastases) remain associated with a very poor prognosis linked to significant therapeutic resistance. Thus, glioblastoma, which is the most common and aggressive primary brain tumor in adults, is associated with inevitable relapses within 7 to 10 months and median survival of approximately 12 to 14 months. At the same time, brain metastases are increasingly increasing following better systemic control of other metastatic sites and improvement in detection methods. However, they remain resistant to the latest therapeutic innovations such as immunotherapies or targeted therapies. In this context, innovative strategies are necessary to identify new therapeutic targets and implement new treatments to overcome resistance phenomena in the clinic. Objective: Our goal will be to generate tumoroids and stem-like cell lines (PDX) from patient tumor samples. Methods: We will establish tumor tumoroids and stem cell lines from patient samples. These preclinical models will allow us to test a large number of drugs, quickly and efficiently thanks to models as close as possible to patient tumors and limiting the use of animal models (3R). Overall, this project should enable major advances in the treatment of glioblastoma and brain metastases and enable the rapid testing of new molecules in clinical trials thanks to the homology of our models with our patients' diseases.